Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

NCT02313584 | Unknown Phase 3

• 1 other identifier: anam6394
• Study Type: interventional
• Target: 464
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.

Conditions

Atrial Fibrillation; Thromboembolism

Keywords

dabigatran

Outcome Measures

Primary Outcomes (1)

• The rate of thromboembolic events

  2 months

Study Arms (2)

Short Group

ACTIVE COMPARATOR

The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

Drug: dabigatran

Conventional Group

PLACEBO COMPARATOR

The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

Drug: placebo

Interventions

dabigatran DRUG

Short Group

placebo DRUG

Conventional Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paroxysmal AF undergoing catheter ablation
• CHA2DS2-VASc score \<= 1
• informed consent

You may not qualify if:

• persistent AF
• CHA2DS2-VASc score \> 2
• prior CVA
• prior atnicoagulant
• severe HF
• abnormal liver or renal function
• history of severe bleeding

Sponsors & Collaborators

• Korea University: lead

MeSH Terms

Conditions

Atrial Fibrillation; Thromboembolism

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Young-Hoon Kim

CONTACT

82-2-920-6700; yhkmd@unitel.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 10, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: December 10, 2014

Record last verified: 2014-12